Test-Retest Variability and Discriminatory Power of Measurements From Microperimetry and Dark Adaptation Assessment in People With Intermediate Age-Related Macular Degeneration – A MACUSTAR Study Report

Abstract

Purpose The purpose of this study was to assess test-retest variability and discriminatory power of measures from macular integrity assessment (S-MAIA) and AdaptDx. Methods This is a cross-sectional study of 167 people with intermediate age-related macular degeneration (iAMD), no AMD (controls; n = 54), early AMD ( n = 28), and late AMD ( n = 41), recruited across 18 European ophthalmology centers. Repeat measures of mesopic and scotopic S-MAIA average (mean) threshold (MMAT decibels [dB] and SMAT [dB]) and rod intercept time (RIT [mins]) at 2 visits 14 (±7) days apart were recorded. Repeat measures were assessed by Bland-Altman analysis, intra-class correlation coefficients (ICCs) and variability ratios. Secondary analysis assessed the area under the receiver operating characteristic curves (AUC) to determine the ability to distinguish people as having no AMD, early AMD, or iAMD. Results Data were available for 128, 131, and 103 iAMD participants for the mesopic and scotopic S-MAIA and AdaptDx, respectively. MMAT and SMAT demonstrate similar test-retest variability in iAMD (95% confidence interval [CI] ICC of 0.79–0.89 and 0.78–0.89, respectively). ICCs were worse in RIT (95% CI ICC = 0.55–0.77). All tests had equivalent AUCs (approximately 70%) distinguishing between subjects with iAMD and controls, whereas early AMD was indistinguishable from iAMD on all measures (AUC = <55%). A learning effect was not seen in these assessments under the operating procedures used. Conclusions MMAT, SMAT, and RIT have adequate test-retest variability and are all moderately good at separating people with iAMD from controls. Translational Relevance Expected levels of test-retest variability and discriminatory power of the AdaptDx and MAIA devices in a clinical study setting must be considered when designing future trials for people with AMD.

Inter and intradevice assessment of microperimetry testing in aging eyes

“…Repeatability between the first and the second used device was almost identical suggesting no influence of weariness or learning effect. Similar findings have been reported by other study groups 15 . The shorter test duration of the second examination should be attributed to the used “follow up” function offered by each device instead of a potential learning effect.…”

“…Palkovits et al analysed test-retest repeatability for Nidek MP-3 on ten healthy subjects and found similar mean PWS (29.8 ± 0.9), limits of agreement of the Bland-Altman plots (+ 3.54 and − 3.02 dB) and CoR (±3.3 dB) 16 . A similar reproducibility could be attained for test re-test repeatability with the CentreVue MAIA under mesopic conditions while comparing our results to those of Pfau et al who found a CoR of 4.75 dB and similar LoA (+ 4.29 to − 5.08 dB) 24 or Higgins, Bethany E. et al who reported a SD of the within subject differences of 2.62 in a healthy population 15 .…”

“…Previous studies have evaluated test-retest repeatability of MAIA and MP3 devices in healthy patients 15 – 18 . These studies have mostly analysed only one of the two devices and often on healthy young subjects.…”

Retinal sensitivity changes in early/intermediate AMD: a systematic review and meta-analysis of visual field testing under mesopic and scotopic lighting

“…At the summary level, we found that almost all the above modifiable factors were insignificant, as validated in other studies [ 14 , 110 , 111 ]. This is particularly relevant for research groups seeking to validate functional endpoints for AMD (e.g., the ALSTAR2 [ 20 ] and MACUSTAR groups) [ 112 ], whereby the time saved from not performing protracted dark adaptation for mesopic testing, in particular, could be redirected elsewhere. Consistent application of testing protocol at the individual patient level (within populations) is likely still important [ 14 , 25 – 30 , 32 – 40 , 108 , 109 ].…”